MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; Implantable Lead

Model Number	4542
Medical Device Problem Codes	Failure to Capture (1081); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician suspected that this left ventricular (lv) lead had fractured and was concerned about potential loss of capture.Boston scientific technical services (ts) was contacted and was unable to determine if the lv lead was truly capturing or not.Therefore, ts recommended that the patient be evaluated in-clinic to ensure adequate capture.At this time, this lv lead remains implanted and in-service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the physician suspected that this left ventricular (lv) lead had fractured and was concerned about loss of capture.Boston scientific technical services (ts) was contacted and was unable to determine if the lv lead was truly capturing or not.Therefore, ts recommended that the patient be evaluated in-clinic to ensure adequate capture.This loss of capture was confirmed in-clinic.However, as the patient would like to avoid surgical intervention, the physician elected to continue with close remote monitoring.Recently, the physician surgically capped and abandoned this lead.A new lead was subsequently implanted to resolve the event and no additional adverse patient effects were reported.This lv lead remains implanted, but is capped and out-of-service.
Additional Manufacturer Narrative
Device technical analysis: this product has not been returned to boston scientific, and as a result, a laboratory analysis could not be conducted.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of fracture was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• Brand Name: EASYTRAK 2 IS-1
• Common Device Name: Implantable Lead
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; road 698, lot no. 12; dorado PR 00646 -260; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25630314
• Report Number: 2124215-2026-33992
• Device Sequence Number: 21269736
• Product Code: NIK
• UDI-Device Identifier: 00802526410901
• UDI-Public: (01)00802526410901(17)160728
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/28/2016
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 302163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Supplement Date Received by Manufacturer: 06/25/2026; Not provided; 09/03/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 07/21/2026; 09/04/2026; 09/09/2026
• Date Device Manufactured: 07/28/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male